The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Ll100 Cryosurgical System.
| Device ID | K803311 |
| 510k Number | K803311 |
| Device Name: | LL100 CRYOSURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | WALLACH SURGICAL DEVICES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-02 |
| Decision Date | 1981-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937010093 | K803311 | 000 |
| 00888937002799 | K803311 | 000 |
| 00888937002782 | K803311 | 000 |
| 00888937002775 | K803311 | 000 |
| 00888937002768 | K803311 | 000 |
| 00888937002751 | K803311 | 000 |
| 00888937002744 | K803311 | 000 |
| 00888937002737 | K803311 | 000 |
| 00888937002720 | K803311 | 000 |
| 00888937002713 | K803311 | 000 |
| 00888937002706 | K803311 | 000 |
| 00888937002690 | K803311 | 000 |
| 00888937002683 | K803311 | 000 |
| 00888937002676 | K803311 | 000 |
| 00888937002805 | K803311 | 000 |
| 00888937002812 | K803311 | 000 |
| 00888937002829 | K803311 | 000 |
| 60888937010086 | K803311 | 000 |
| 60888937010079 | K803311 | 000 |
| 50888937009885 | K803311 | 000 |
| 00888937009828 | K803311 | 000 |
| 00888937009811 | K803311 | 000 |
| 00888937009804 | K803311 | 000 |
| 00888937009798 | K803311 | 000 |
| 00888937002881 | K803311 | 000 |
| 00888937002874 | K803311 | 000 |
| 00888937002867 | K803311 | 000 |
| 00888937002850 | K803311 | 000 |
| 00888937002843 | K803311 | 000 |
| 00888937002836 | K803311 | 000 |
| 00888937002669 | K803311 | 000 |